CVT-SFA First in Human Trial for Treatment of Superficial Femoral Artery or Proximal Popliteal Artery

Inclusion Criteria

• Subject must be at least 18 years of age.
• Subject or his/her legally authorized representative provides written informed consent prior to any clinical investigation related procedure, as approved by the appropriate Ethics Committee of the respective clinical site.
• Subject must agree to undergo all clinical investigation plan-required follow-up visits and examinations.
• Subjects with symptomatic leg ischemia, requiring treatment of SFA or popliteal (P1 segment) artery.
• De novo or restenotic lesion(s) >70% within the SFA and popliteal arteries in a single limb which are ≥3 cm and ≤15 cm in cumulative total length (by visual estimation). Lesion must be at least 2 cm from any stented area.
• Subject is willing to comply with the required follow up visits, testing schedule and medication regimen.
• Successful wire crossing of lesion.
• Target vessel reference diameter ≥4 mm and ≤6 mm (by visual estimation).
• Target lesion(s) can be treated with a maximum of two (2) CVT Everolimus-coated PTA Catheters.
• At least one patent (less than 50% stenosis) tibio-peroneal run-off vessel confirmed by baseline angiography or prior MR angiography or CT angiography.
• Life expectancy >1 year
• Rutherford classification of 2, 3 or 4.

Exclusion Criteria

• Pregnant or lactating females.
• Co-existing clinically significant aneurismal disease of the abdominal aorta, iliac or popliteal arteries.
• Significant gastrointestinal bleeding or any coagulopathy that would contraindicate the use of anti-platelet therapy.
• Known intolerance to study medications, everolimus or contrast agents.
• Doubts in the willingness or capability of the subject to allow follow-up examinations.
• Subject is actively participating in another investigational device or drug study.
• History of hemorrhagic stroke within 3 months of procedure.
• Previous or planned surgical or interventional procedure within 30 days of index procedure.
• Prior vascular surgery of the target lesion.
• Lesion length is 15 cm or there is no normal proximal arterial segment in which duplex ultrasound velocity ratios can be measured.
• Known inadequate distal outflow.
• Significant inflow disease.
• Acute or sub-acute thrombus in target vessel.
• Use of adjunctive therapies (i.e. laser, atherectomy, cryoplasty, scoring/cutting balloons, brachytherapy, lithotripsy).
• Outflow arteries (distal popliteal, anterior or posterior tibial or peroneal arteries) with significant lesions (≥ 50% stenosis) may not be treated during the same procedure.
• Treatment of the contralateral limb during the same procedure or within 30 days of the study procedure.
• Rutherford classification of 0, 1, 5 or 6
• Presence of prohibitive calcification that precludes adequate PTA treatment.
• Subjects held in custody in an institution by official or court order.